# Augustine Biomedical & Design, LLC

- Location (FDA's records): Eden Prairie, MN
- FDA decisions: 4 (2006–2011): 4 510(k) clearances
- Product codes: DWJ (4)
- Predicates its devices cite: 8 (4 its own); citations of its devices by later devices: 11 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Augustine Medical, Inc.: 2 (https://510kreport.com/company/augustine-medical)
- Microtek Medical, Inc.: 1 (https://510kreport.com/company/microtek-medical)
- Inditherm Medical: 1 (https://510kreport.com/company/inditherm-medical)

## Firms that cite its devices most
- Augustine Temperature Management, LLC: 2 (https://510kreport.com/company/augustine-temperature-management)
- STERIS Corporation: 1 (https://510kreport.com/company/steris)
- Geratherm Medical AG: 1 (https://510kreport.com/company/geratherm-medical)
- Stihler Electronic GmbH: 1 (https://510kreport.com/company/stihler-electronic)
- Molnlycke Health Care Us, LLC: 1 (https://510kreport.com/company/molnlycke-health-care-us)
- Vitaheat Medical, LLC: 1 (https://510kreport.com/company/vitaheat-medical)

## Its most-cited devices
- K052392: Hot Dog Patient Warming System (2006), cited by 5
- K112488: Hotdog Patient Warming System (2011), cited by 3
- K092807: Hot Dog Patient Warming Mattress System, Models Wcub, M101, M102 and M103 (2009), cited by 2
- K094056: Hotdog Multi Function Controller (2010), cited by 1

## Recent decisions
- K112488: Hotdog Patient Warming System (Nov 23, 2011)
- K094056: Hotdog Multi Function Controller (Jun 3, 2010)
- K092807: Hot Dog Patient Warming Mattress System, Models Wcub, M101, M102 and M103 (Dec 10, 2009)
- K052392: Hot Dog Patient Warming System (May 4, 2006)

Source page: https://510kreport.com/company/augustine-biomedical-design